Entraining biological calculi

ABSTRACT

A medical device for entraining biological stones during medical procedures for the fragmentation of urinary, biliary, pancreatic, and other biological calculi and safely removing them from the body. The device includes a guidewire having a longitudinally-extending wire core. A portion of the wire core more adjacent the distal end thereof than the proximal end thereof is wound to form a helical coil which tapers in diameter from a larger diameter end at the proximal end thereof to a smaller diameter end at the distal end thereof. At least a portion of the core forming said helical coil is made of a super-elastic deformable material which collapses upon retraction into a tubular sheath and which reforms into a coil upon deployment from the sheath.

FIELD OF THE INVENTION

This invention relates to medical treatments for biological concretionsand more specifically, to devices and methods for entraining andextracting these concretions such as urinary, biliary, and pancreaticstones, and other calcified material or debris from the body.

BACKGROUND OF THE INVENTION

Urolithiasis, or kidney stone disease, is a significant health problemin the United States. It is estimated that between 2-5% of the generalpopulation will develop a urinary calculus during their lifetime. Sincebeing introduced in the 1980s, minimally invasive procedures such aslithotripsy as well as ureteroscopy have become the preferred methodsfor treatment in a majority of cases of stones in the ureter, and have apotential for application to concretions that develop in other parts ofthe body such as the pancreas and the gallbladder.

Lithotripsy is a medical procedure that uses energy in various formssuch as acoustic shock waves, pneumatic pulsation, electrical hydraulicshock waves, or laser beams to break up biological concretions such asurinary calculi (e.g. kidney stones). The force of the energy, whenapplied either extracorporeally or intracorporeatly, usually in focusedand continuous or successive bursts, comminutes a kidney stone intosmaller fragments that may be extracted from the body or allowed to passthrough urination. Applications to other concretions formed in the body,such as pancreatic, salivary and biliary stones as well as the vascularsystem, are currently underway in several research laboratories acrossthe United States and Europe.

With the help of imaging tools such as transureteroscopicvideotechnotogy and fluoroscopic imaging, the operator of thelithotripter device can monitor the process of the procedure andterminate treatment when residual fragments are small enough to bevoided or grasped and removed. Currently, more than 2000 extracorporeallithotripter devices and thousands of intracorporeal lithotripterdevices are in operation around the world and over five milliontreatments have been performed.

Although these promising new techniques and instrumentation haveimproved the treatment of kidney and other biological stones, someproblems remain. For example, stones in the ureter which are treated byintracorporeal methods of fragmentation may become repositioned closerto the kidney, and it then becomes necessary to prevent retrograde, i.e.cephalad or upward, migration of the stone fragments toward the kidney.It is also desirable to be able to extract such fragments from the bodywith the same instrument, preventing the need for successiveinstrumentation.

The prior art teaches several types of stone extraction devices whichare designed to extract biological concretions without the necessity ofmajor open surgery. However, each of these devices suffers fromlimitations. Most of these devices comprise curved wires which form acage or basket; see, e.g., U.S. Pat. Nos. 2,943,626, 3,472,230,4,299,225, 4,347,846, and 4,807,626. The cage or basket-likeconfiguration entrains a single stone within the wire frame; but theseprior art devices have rigid frames that lack the maneuverability andflexibility to engage and disengage a stone repeatedly without causingharm to the surrounding tissue, and the entraining portion of theseprior art devices are often rigid and are either not collapsible into asmaller configuration or require mechanisms for opening or closing thebasket. If the basket or cage of the device itself has become trappedwithin the ureter, a second device often must be deployed to retrievethe first basket from the body; and if the basket or coil structure hasentrained a stone which is too large to be extracted without furtherfragmentation, it also may be difficult to disengage the stone without asignificant amount of manipulation.

Another prior art device comprises one or two inflatable ballooncatheters that are manipulated so that the arrested stone is caughtbetween one or more of the balloons. The balloon is slowly withdrawnfrom the body, and if there are two balloons, the lower balloon acts asa dilator of the ureteral wall and the upper balloon pushes the stonedownward towards the bladder. See, e.g., U.S. Pat. No. 4,295,464. Theballoons of such devices are difficult to manipulate and failure tomaintain the balloons in the correct spatial position may result in lossof the stone. Further, if a stone is caught in a narrow passagewayduring the extraction process, the balloon catheters cannot move thestone away from the exit direction to dislodge it from the passageway;and if the stone is caught in between the lining of the ureteral walland the balloon, the pressure of the balloon may push the stone into thelining, causing significant damage to the lining. Also, softair-inflated balloons are easily punctured when used in conjunction withmost types of stone fragmentation procedures.

There is a particular need, therefore, for a guidewire device thatprevents upward migration of stone fragments generated during a stonefragmentation procedure, and which safely and efficiently extractsfragments from the body. Thus, a device possessing the followingabilities is desired: ability to act as an energy-absorbing barrier thatprevents fragments from migrating toward the kidney; ability to “sweep”one or multiple smaller fragments downward and out of the body; theability to engage and disengage the stone repeatedly, and the ability todisengage the stone for repositioning for further fragmentation if theentrained stone is too large to pass from the body.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide aflexible, form-fitting device which prevents upward migration ofbiological stones and fragments of stones generated during medicalprocedures for stone fragmentation. It is another object of theinvention to provide a device in which the entraining configuration maybe collapsed and redeployed repeatedly as required during a stonefragmentation procedure.

A further object-of the invention is to provide a device which cansafely guide the one or multiple stone fragments from the body, sweepingit downward and which as a safety feature, disengages itself from astone that is too large to pass a specific path in the body by a simplepulling motion.

The invention features a device comprising a wire core at least aportion of which is comprised of a super-elastic deformable materialwound to form a helical coil which tapers from a larger diameterproximal end to a smaller diameter distal end. Because the coil portionof the core is formed of a super-elastic material, preferably a nickeltitanium alloy such as nitinol, the coil has the ability to uncoil intoa relatively straight configuration when retracted into a tubular sheathor pulled against an obstruction, and reform into a coil configurationwhen deployed, e.g. withdrawn from, a tubular sheath. In preferredembodiments, a continuous super-elastic wire core is surrounded by awrapped helical spring, typically having two sections which are attachedto each other and to the core at a midjoint proximal to the taperedhelical coil. Another preferred embodiment features a layer of polymericmaterial covering the surface or at least a portion of the device, aswell as a layer of radiopaque material which covers at least a portionof the tubular sheath and/or the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 generally shows one preferred embodiment of the claimed devicefor a urinary application.

FIG. 1A is an enlarged view of the tapered helical coil portion of thedevice of FIG. 1.

FIG. 2 is a schematic view of the wire core of the device of FIG. 1.

FIG. 3 is a schematic view of two wrapped helical springs generallycoated with a polymeric material.

FIG. 4 is a detailed schematic of a wrapped helical spring 18 of FIG. 3,a portion of which has been stretched so that gaps are introducedbetween adjacent turns of the spring.

FIGS. 5A and 5B are profile views of the device of FIG. 1, respectivelyillustrating the helical coil of the device withdrawn into, and fullydeployed (i.e. withdrawn) from the sheath.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference to FIGS. 1 and 1A, a medical device 8 embodying thepresent invention includes a wire core 10 having a super-elastic,tapered helical coil portion 14 adjacent but spaced a short distancefrom its distal end 11. Except at its extreme ends, wire core 10 issurrounded by two wrapped helical springs 18, 20, which in turn arecovered with a layer of a polymeric material. Hereinafter, the wire core10, the helical spring(s) surrounding the core, and the layer ofpolymeric material (if any) may be collectively referred to as theguidewire 9. As shown in FIG. 1, a portion of the guidewire 9 proximalto the helical coil section 14 is surrounded by an axially-movabletubular sheath 24. The distal end 11 and the proximal end 13 of the wirecore 10 are rounded; typically a hemispherical tip 15 is bonded to thedistal end 11. It will be appreciated that FIG. 1 is not to scale; theoverall length of the device is over one hundred times its maximumdiameter.

The overall length of guidewire 9 (and thus that of wire core 10)depends on the application for which the device is intended. Generallythe overall length will be in the range of about 50 to about 250 cm. Forurinary applications, the total length of the device is preferably about140-220 cm, and to most preferably about 200 cm. Devices for otherapplications, or those intended for use with children, will be ofdifferent lengths.

As described below, wire core 10 preferably has a tapered cross-section.

The maximum diameter of the wire core 10 itself is typically in therange of about 0.015 inches to 0.04 inches, and preferably is about0.020 inches. The overall diameter of the guidewire 9 is slightlygreater, e.g., in the preferred embodiment, it is about 0.038 inches andmay, depending on the particular device, vary from about 0.018 to 0.05inches.

The helical coil section 14 of wire core 10 has a maximum diameter atits proximal end, and a minimum diameter at its distal end. The smallerdiameter, i.e., the distal end of coil 14 is spaced a relatively shortdistance 12 (e.g., about 2 cm to about 50 cm, preferably about 10-24 cm,most preferably about 14 cm) from the distal end 11 of device 8. Theportion 16 of core 10 proximal of the helical coil section 14 is about50 cm to about 200 cm long; the overall length is usually not criticaland, like many of the other particular dimensions of the device, dependson the intended use. Typically, the length of the proximal portion 16 ofthe core wire 10 is about 100 to 130 cm, and preferably about 120-130cm.

The particular number of turns, the maximum diameter, and the length ofthe tapered helical coil section 14 depends, again, on the intended useof device 8. Typically, the coil has between about 5 and 15 turns, andpreferably about 7 to 10 turns. Its maximum diameter, at the proximalend of the helical coil section 14 is in the range of about 0.2 cm to3.0 cm; and for usual applications is about 0.5-1.5 cm, and mostpreferably is about 0.7-0.8 cm. The overall length of the coil depends,of course, on such things as the wire size and number of turns, buttypically is in the range of about 0.5 cm to about 3.0 cm; and for mostapplications is preferably about 1.5 cm. Adjacent turns of the coil mayabut each other. Typically, and as best shown in FIG. 1A, there may besmall gaps 26, up to about 2 mm wide, between the adjacent wire turnsforming the tapered helical coil. As will be discussed in detail later,at least the portion of the wire core 10 forming the tapered helicalsection is made of a super-elastic material, and the above dimensionsare those of the coil when it is in its set, or fully deployed,configuration, as shown in FIG. 1.

A pair of wrapped helical springs 18, 20 surround essentially the entirelength of wire core 10, except for relatively short (i.e., less than0.050 inch long) regions at the extreme distal end 11 and proximal end13. One of the springs, designated 18, tightly surrounds the portion ofthe wire core 10 extending from adjacent the proximal end 13 of the core10 to a region 22 a short distance proximal of the tapered helical coilsection 14. A second wrapped helical spring 20 tightly surrounds theportion of the wire core 10 (including the helical spring portion 14)extending distally from region 22 to adjacent the distal end 11 of thewire core 10.

Preferably, the helical spring 18 has a length of about 150-180 cm, mostpreferably about 160 cm, and the helical spring 20 has a length of about10-50 cm, most preferably about 40 cm. The adjacent ends of the twosprings 18, 20 are attached both to each other and to the surroundedcore 10 at region 22, herein referred to as a midjoint or midjointregion, proximal of the helical coil section 14. Preferably, themidjoint has a length of about 0.02 to 0.06 inches, most preferablyabout 0.03-0.04 inches. It is also preferred that the two springs arewrapped in the same direction, e.g., right-hand wrapped, and the turnsat what will be the adjacent ends of the two springs are slightlystretched, so that the turns of the springs at midjoint 22 can be coiledone into the other, interlocking in a fashion similar to that of afinger joint. Preferably, about 0.5 to 2 turns of the adjacent ends ofthe two springs are stretched and interlocked with one another. FIG. 4illustrates a stretched turn having gaps 50 between adjacent turns ofspring 18.

These inter-connected turns are further attached to each other and tothe wire core 10, typically with an adhesive that can form ahigh-strength bond with a wide variety of substrates, particularly metaland polymeric materials. Once the adhesive is applied, it typically iscured by a conventional curing method, such as heat setting andair-drying. It is preferred that the adhesive comprise epoxy, preferablya UV curing adhesive that offers a secondary heat cure capability toallow areas shadowed from ultraviolet light to be cured with heat, suchas that identified by the trade name Dynam 128-M-VT. In some otherembodiments, other means of attachment may be employed, preferablywelding or brazing.

In the preferred embodiment, spring 18 is wound from a larger diameterwire than is spring 20; e.g., proximal spring 18 is wound from wirehaving a diameter of about 0.008 in. while the wire from which distalspring is wound has a diameter of about 0.004 in. It has been found thata larger diameter proximal helical spring 18 provides the proximalportion of the device 8 with greater rigidity and column strength; andthat the use of a smaller diameter distal helical spring 20 provides thedistal portion of the device with greater flexibility. In otherembodiments, however, the arrangement may be somewhat different. Forexample, both the distal and proximal springs may have the samediameter, or only a single spring extending substantially the entirelength of the wire core may be used. Regardless of the number of springsor their diameters, the springs may be made of a wide range ofmaterials; and the springs are wound so that their outer diameters donot exceed the desired outer diameter, e.g., 0.038 inches, of theguidewire. Typically the springs are made of stainless steel.

FIG. 2 shows the construction of the wire core 10, which, in thepreferred embodiment, is a commercially available NiTiCr (55.73% Ni,44.04Ti, 0.22% Cr, and less than 0.05% C and O) superelastic wirehaving, as supplied, a diameter of 0.020 inches. As shown the wire hasbeen ground so that, in addition to full diameter sections 33 and 34adjacent, respectively, its distal and proximal ends, it includes a pairof tapered portions 30, 32 on opposite sides of a smaller diameterportion 31. The long full diameter section 34 extending from theproximal end of the core wire, and the longer tapered portion 30,provide desired column strength in the portion of the core wire proximalof the smaller diameter portion 31. Preferably, the long full diametersection 34 has a length of about 130-200 cm, most preferably about 150cm and a diameter of about 0.02 inches. Preferably, the smaller diameterportion 31 has a length of about 20-40 cm, most preferably about 30 cmand most preferably a diameter of about 0.009 inches. The longer taperedportion 30 is preferably about 5-10 cm in length, most preferably about8 cm, and the shorter tapered portion 32 preferably has a length ofabout 0.01 to 0.05 inches, most preferably 0.025 inches. The shorterfull diameter section 33 preferably has a length of about 0.1 to 0.5inches, most preferably about 0.2 inches.

The smaller diameter portion 31, which as discussed above, forms helicalcoil 14. Typically, the lengths of springs 18, 20 are such that themidjoint region 22 of core 10 is part of smaller diameter portion 31.The smaller diameter portion 31 of the core wire 10 immediately distalof the helical coil provides the flexibility required for variousapplications involving the entraining and removal of biological calculi.

In the preferred embodiment, the entire wire core 10 is a continuouspiece of super-elastic wire; in other embodiments, the portion of thecore wire 10 that will form helical coil 14 will be superelastic, butother portions of the core wire, e.g., the full diameter section 34 andtapered portion 30, may be stainless steel. A number of superelasticNiTi alloys, commonly referred to as nitinol, are availablecommercially.

The helical coil portion 14 of core wire 10 is formed by wrapping thesmaller diameter portion 31 around a mandrel to form it into the desiredconical shape, and then heating it at sufficient time and temperature(the particular time and temperature depend on the particularsuperelastic material and are conventional) to set the conically-shapedcoil in the core wire. As is well-known in the art, once the portion ofthe core wire forming coil 14 has been heat-treated to set the desiredtapered helical coil configuration, the coil may be drastically deformed(e.g., by pulling the core wire portions on either side of the coil tostraighten the wire turns forming the coil) but will return to its settapered coil configuration when released. It will be apparent that thesedeformation/reconformation characteristics are important to the use ofthe medical device. They also assist in the device's construction, e.g.,by permitting the core wire to be straightened so that helical spring 20may more easily be slid over the distal portion of the core wire, overthe portion of the wire that forms coil 14, to midjoint region 22.

As discussed above, in the preferred embodiment of the invention, ahelical spring covers most of the length of the core wire 10. In otherembodiments, the use of such a spring may be omitted. In either event, alow-friction layer of polymeric material preferably covers the outersurface of the device, i.e., the outer surface of the core wire when nospring is used or, if the core wire is wrapped with one or two helicalsprings, the outer surface of the spring(s). FIG. 3 illustrates awrapped helical spring 18 which has been covered, typically byspray-coating, with a layer of polymeric material 40. As will be noted,the coating 40 does not cover small lengths 42, 44 at the proximal anddistal ends of spring 18.

Although any of a wide range of low-friction materials may be used toform the coating 40, the coating of the preferred embodiment is afluorinated polymer, e.g., polytetrafluoroethylene, one type of which issold by duPont de Nemours Co. under the trademark TEFLON. In someembodiments, various portions of the device are coated with polymericmaterials of different colors. For example, as shown in FIGS. 5A and 5B,a colored portion 70 of core 10 that is at least as long in length asthe length of the helical coil 14 may be coated with a polymericmaterial of a color different than that of the rest of the deviceproximal and/or distal of it; or in some embodiments may be leftuncolored or uncoated. As will be apparent, providing a colored portion70 that possesses a color different from that of the rest of the deviceassists a user in determining whether the tapered helical coil is withinor without sheath 24. Thus, when the coil has been retracted into thesheath 24, the colored portion 70 will be visible to the user. When thecoil has been withdrawn outside the sheath 24 (i.e. deployed), thecolored band 70 will no longer be visible to the user.

Sheath 24 has a length that is less than the overall length of guidewire9, but is considerably more than the length of wire core 10 forming thehelical spring portion 14 so that a physician using device 8 can graspthe proximal end of the sheath when the device has been properlypositioned within a patient. The inner diameter of sheath 24 is slightlygreater than that of the diameter of the wrapped spring that surroundshelical spring portion. Its outer diameter depends, principally, on thewall thickness and strength required to retain the portion of wire core10 forming spring 14 in a relatively straight configuration when thehelical coil spring is drawn into the sleeve, i.e. sheath 24. Forexample, in the preferred embodiment, sheath 24 is 75 cm long, has aninner diameter of 0.043 inches and an outer diameter of 0.066. Thematerial of which the sheath is made also must be somewhat flexible, sothat the sheath can be introduced into the body along with the rest ofthe device. In the preferred embodiment, the sheath is made of aflexible polymeric material such as that sold under the trade namePEBAX, and its distal portion is covered with a radiopaque material 80to assist a user in locating the distal end of the sheath during amedical procedure.

FIGS. 1 and 5B illustrate device 8 with sheath 24 positioned proximallyof helical coil portion 14. As will be appreciated, in this relativelypositioning of the coil and sheath, the helical coil portion 14 isunconstrained and conforms to the tapered, helical configuration inwhich the nitinol (or other superelastic material) forming the coilportion was heat set. FIG. 5A illustrates device 8 with the sheath 24and helical coil portion 14 moved axially relative to each other so thatthe helical coil portion has been retracted into the sheath. As shown,the super-elastic qualities of the material forming the coil portionpermit it to be deformed into an essentially straight configuration 60,in which the coil portion of guidewire 9 fits into the sheath whoseinner diameter is only slightly (e.g., in the preferred embodiment about0.005 inches) greater than the outer diameter of the wrapped wire core.If the super-elastic portion of the coil wire that has been set in thehelical coil configuration is then withdrawn from sheath 24, e.g., bymoving the sheath proximally relative to the core wire (or the core wiredistally relative to the sheath), it will reform the tapered helicalspring configuration shown in FIG. 5B.

In use, device 8 is provided to a physician performing the desiredmedical procedure, e.g., a lithotripsy to remove kidney stones from apatient's ureter, in the configuration shown in FIG. 5A, with sheath 24surrounding the helical coil portion 14 of the guidewire 9. The sheathedguidewire is then introduced into the patient's urinary passage,typically with its progress being monitored in the conventional manner,until the radiopaque distal portion 80 of sheath 24 is slightly beyondthe location of the stone or other biological calculus lodged in theureter. With the sheath held in place, the guide wire is then advancedso that the portion of the guidewire forming helical coil portion 14 isdeployed distally from sheath 24 and forms the tapered, helical coilconfiguration, occluding the passageway.

Preferably, the diameter of the largest portion of the helical coilportion 14, in its fully deployed configuration (e.g., the configurationin which it was set during manufacture) is the same or slightly greaterthan that of the hollow passage (e.g., the ureter) in which the coilwill be deployed in the course of a medical procedure. This insures thatthe outer diameter of the coil will conform to the size of the passageand occlude it efficiently, preventing migration of the kidney store orother calculus.

With the coil thus deployed, energy is applied to the stone or othercalculus, in the same manner as in conventional lithotripsy, to breakthe stone into smaller fragments that may either be extracted or allowednormally to pass from the body. During the fragmentation procedure, thedeployed coil functions as a physical barrier, trapping the larger stoneor calculus fragments either within the coiled structure or proximal tothe coil. The smaller fragments, e.g., those that are able to passbetween the turns of the helical coil 14, are typically of such sizethat they can pass normally from the body. The super-elasticity of thematerial forming the coil, particularly when combined with the taperedconfiguration, provides a flexible barrier that is able to absorb thekinetic energy of the fragments produced when a laser or other energy isused to comminute or ablate the calculus.

In some procedures, the deployed coil can be used as a “basket,” tocapture the fragments and permit them to be withdrawn from the body bywithdrawing the guidewire 9 with the helical coil portion in itsdeployed configuration. In other procedures, the deployed coil isretracted back into sheath 24, and then repositioned for furtherdeployment.

The following examples will further illustrate the invention. Theseexamples are not intended, and should not be interpreted, to limit thescope of the invention.

EXAMPLE I

The device was tested in vitro under conditions that simulated theureter and utilizing various particles that simulated stone fragments.The test ureter consisted of a clear plastic tube having an innerdiameter of about 10 mm with openings to introduce particles and thedevice. A pump with a flowrate of 1L/min was connected to the testdevice to simulate the high intensity with which fragmentary debrisgenerated during lithotripsy will flow into the tapered helical coilthat has been deployed within the ureter.

Four different kinds of particles were used to simulate stone fragments:

-   -   1) Crushed walnut shells: various jagged shaped (about 2 mm at        its greatest length).    -   2) Zircon oxide beads: spheroidal beads (about 2.0 to 2.5 mm in        diameter).    -   3) Steel ball bearings: spheroidal balls (about 4.7 mm diameter)    -   4) Plastic beads: spheroidal balls (about ⅛ inches diameter).

The test was conducted by introducing the device and deploying it withinthe clear plastic tube. The particles were then introduced into thewater stream flowing into the tube. The device successfully collectedall of the tested particles.

EXAMPLE II

In another series of experiments, the same equipment described above wasused. In addition, actual kidney stones were used as test particlesalong with the simulated fragments listed above. A lithotripter,specifically CALCUSPLIT Model #276300 (Storz) was used to fragment thestone that was entrained within the cone of the tapered helical coil.The coil secured the stone while a probe of the lithotripter devicefragmented it. Tables 1 and 2 provide the results of these preliminaryexperiments and provide information about the sizes and weight offragmented debris collected and passed by the device during a laserlithotripsy procedure. TABLE I With Stone Stopper Stone Size & WeightSize & Weight Size & Weight Stone Before of Debris of Debris Sample TypeBreaking* Passed* Captured* 1A Uric Acid 6.34 mm/ 4 mm/>.01 gm 4 mm/.03gm 1.42 gm 1B Uric Acid 6.31 mm/ 3.5 mm/.01 gm 5.5 mm/.07 gm 1.34 gm 2AUric Acid 6.26 mm/ 3 mm/>.01 gm 3 mm/.07 gm 1.43 gm 3A** Struvite/ 6.71mm/ 1 mm/.01 gm 2 mm/>.01 gm Apatite 1.31 gm 4A*** Cystic 6.64 mm/ 4mm/>.01 gm 3.5 mm/.02 gm (hard) 1.42 gm 5A Black 6.55 mm/ 1 mm/>.01 gm2.5 mm/>.01 gm 1.29 gm*Size is determined by the largest measured dimension of the particle.**Debris comprises fine and powdery grains.***Stone ablated using laser lithotripsy.

TABLE 2 Size of Debris & Weight of Size of Debris & No. of Pieces DebrisNot Debris Type No. of Pieces* Not Entrained* Entrained Kidney Stone ˜8mm dia./1 pc. <.5 to 3 mm/ .05 grams (Struvite, soft) 20 to 25 pcs.Kidney Stone ˜8 mm dia./1 pc. ˜6 mm/1 pc. .10 grams (hard) Walnut Shell2.8-3.9 cm/16 pcs. None passed None passed Walnut Shell 2.8-3.9 cm/4pcs. None passed None passed*For determining the size of the debris, the largest measurement of theirregular shape was recorded.

The deployed cone containing the particulate matter was then pulleddownward (i.e. in the proximal direction with respect to the device) adistance of 15 cm to simulate extraction of stones entrained within thecoil. It was observed that when fragments of a diameter greater thanabout 4 mm were entrained in the tapered helical coil, the coil thatheld the larger fragment could not be pulled through the plastic tube.The larger fragment's resistance to the pulling force of the user causedthe coil to unwind, letting go of the fragment. The device was thenwithdrawn into the sheath and advanced beyond the fragment. Furtherfragmentation was conducted, and the smaller fragments were thenextracted from the test tubing. It was appreciated that the unwindingfeature of the coil upon pulling against an obstruction provides adesirable safety mechanism, whereby the user is prevented from trying toextract a stone that is too large for the particular passageway, andthus avoiding injury to the ureter. The results of the “putting test”are provided in Table 3. TABLE 3 Size of Debris & Weight of DistanceDebris Type No. of Pieces* Debris Pulled Kidney Stone 6 mm/2 pieces .10grams 15 cm (Struvite, soft) Walnut Shell 2.8-3.9 cm/4 pieces. .08 grams15 cm Walnut Shell 2.8-3.9 cm/16 pieces .30 grams 15 cm*For determining the size of debris, the largest measurement of theirregular shape is recorded.

The various technical and scientific terms used herein have meaningsthat are commonly understood by one of ordinary skill in the art towhich the present invention pertains. As is apparent from the foregoing,a wide range of suitable materials and/or methods known to those ofskill in the art can be utilized in carrying out the present invention;however, preferred materials and/or methods have been described.Materials, substrates, and the like to which reference is made in theforegoing description and examples are obtainable from commercialsources, unless otherwise noted. Further, although the foregoinginvention has been described in detail by way of illustration andexample for purposes of clarity and understanding, these illustrationsare merely illustrative and not limiting of the scope of the invention.Other embodiments, changes and modifications, including those obvious topersons skilled in the art, will be within the scope of the followingclaims.

1. A medical device comprising a generally longitudinally-extending wirecore, a portion of said core more adjacent the distal end thereof thanthe proximal end thereof being wound to form a helical coil which tapersin diameter from a larger diameter end at the proximal end thereof to asmaller diameter end at the distal end thereof, at least the portion ofsaid core forming said helical coil being made of super-elasticdeformable material. 2.-13. (canceled)
 14. The medical device of claim1, wherein said core comprises a super-elastic deformable material. 15.The device of claim 1, wherein said super-elastic deformable material isan alloy comprising nickel and titanium.
 16. The device of claim 15,wherein the alloy consists of nickel, titanium, and chromium. 17.(canceled)
 18. A medical device comprising: a guidewire including alongitudinally-extending wire core, a portion of said core more adjacentthe distal end thereof than the proximal end thereof being wound to forma helical coil which tapers in diameter from a larger diameter end atthe proximal end thereof to a smaller diameter end at the distal endthereof, at least the portion of said core forming said helical coilbeing made of a super-elastic deformable material; and a flexibletubular sheath surrounding a portion of and being movable axiallyrelative to said guidewire, the sheath having an inner diameter that isgreater than the diameter of the guidewire other than a portion of saidguidewire forming said helical coil, such that said coil deforms into aconfiguration having a maximum diameter not more than the inner diameterof said sheath upon retraction into the sheath and returns to a coilconfiguration having a maximum diameter greater than the outer diameterof said sheath upon withdrawal from the sheath.
 19. (canceled)
 20. Amedical procedure comprising the steps of: providing a medical deviceaccording to claim 18 in a configuration in which the helical coil ofthe guide wire of said device is retracted into the tubular sheath ofsaid device; introducing the device in said configuration into a desiredpathway within a body; positioning the device in a desired locationwithin said pathway; moving the helical coil portion of the guidewirerelative to the sheath such that the helical coil portion of the guidewire is withdrawn from the sheath and returns to a coil configurationand in which the coil engages the inner surface of the pathway.
 21. Theprocedure of claim 20, wherein a biological calculus is within saidpathway and said procedure includes fragmentation of the calculus,including the steps of: locating the biological calculus within thepathway; placing at least a portion of the sheathed guidewire beyond thelocation of the calculus; and moving the guidewire relative to thesheath such that the helical coil portion thereof is exposed from thedistal end of the sheath and reforms into a helical coil configurationdistally of the calculus.
 22. The procedure of claim 20, wherein theprocedure further comprises the step of fragmenting a biologicalcalculus located in a desired location in said pathway and distally tothe coil that has engaged the inner surface of the pathway, usinglithotripsy.
 23. The procedure of claim 22, wherein the lithotripsycomprises one of electrohydraulic, pneumatic pulse, acoustic shock wave,and laser lithotripsy.
 24. The medical device of claim 1, wherein atleast a portion of the device includes a layer of radiopaque material.25. The medical device of claim 24, wherein the radiopaque materialcomprises gold, platinum, tantalum, tungsten, iridium, rhodium, rhenium,or an alloy of two or more radiopaque materials.
 26. The medical deviceof claim 18, wherein at least a portion of the flexible tubular sheathcomprises a layer of a radiopaque material.
 27. The medical device ofclaim 26, wherein the radiopaque material comprises gold, platinum,tantalum, tungsten, iridium, rhodium, rhenium, or an alloy of two ormore radiopaque material.
 28. (canceled)
 29. The medical device of claim1, wherein a layer of a polymeric material substantially covers at leastthe portion of said core forming said helical coil.
 30. The medicaldevice of claim 29, wherein a layer of a polymeric materialsubstantially covers the outer surface of the wire core.
 31. The medicaldevice of claim 29, wherein the polymeric material comprises afluorinated polymer.
 32. The medical device of claim 4, wherein thefluorinated polymer is polytetrafluoroethylene.
 33. The medical deviceof claim 1, wherein the wire core is about 50 cm to about 250 cm long.34. The medical device of claim 33, wherein the wire core is about 140cm to about 220 cm long.
 35. The medical device of claim 1 or 30,wherein the wire core is about 0.015 inches (0.381 mm) to about 0.04inches (1.016 mm) in width.
 36. The medical device of claim 1 or 30,wherein the proximal end of the helical coil has a diameter of about 0.2cm to about 3.0 cm.
 37. The medical device of claim 36, wherein theproximal end of the helical coil has a diameter of about 0.5 cm to about1.5 cm.
 38. The medical device of claim 37, wherein the proximal end ofthe helical coil has a diameter of about 0.7 cm to about 0.8 cm.
 39. Themedical device of claim 1, wherein the helical coil comprises betweenabout 5 turns and about 15 turns.
 40. The medical device of claim 1,wherein the distal end of the helical coil is about 2 cm to about 50 cmfrom the distal end of the device.
 41. The medical device of claim 40,wherein the distal end of the helical coil is about 10 cm to about 24 cmfrom the distal end of the device.
 42. The medical device of claim 18,wherein a layer of a polymeric material substantially covers at leastthe portion of said core forming said helical coil.
 43. The medicaldevice of claim 42, wherein a layer of a polymeric materialsubstantially covers the outer surface of the wire core.
 44. The medicaldevice of claim 42, wherein the polymeric material comprises afluorinated polymer.
 45. The medical device of claim 44, wherein thefluorinated polymer is polytetrafluoroethylene.
 46. The device of claim18, wherein said super-elastic deformable material is an alloycomprising nickel and titanium.
 47. The device of claim 46, wherein thealloy consists essentially of nickel, titanium, and chromium.
 48. Themedical device of claim 18, wherein the wire core is about 50 cm toabout 250 cm long.
 49. The medical device of claim 48, wherein the wirecore is about 140 cm to about 220 cm long.
 50. The medical device ofclaim 18 or 42, wherein the wire core is about 0.015 inches (0.381 mm)to about 0.04 inches (1.016 mm) in width.
 51. The medical device ofclaim 18 or 42, wherein the proximal end of the helical coil has adiameter of about 0.2 cm to about 3.0 cm.
 52. The medical device ofclaim 51, wherein the proximal end of the helical coil has a diameter ofabout 0.5 cm to about 1.5 cm.
 53. The medical device of claim 52,wherein the proximal end of the helical coil has a diameter of about 0.7cm to about 0.8 cm.
 54. The medical device of claim 18, wherein thehelical coil comprises between about 5 turns and about 15 turns.
 55. Themedical device of claim 18, wherein the distal end of the helical coilis about 2 cm to about 50 cm from the distal end of the device.
 56. Themedical device of claim 55, wherein the distal end of the helical coilis about 10 cm to about 24 cm from the distal end of the device.
 57. Themedical device of claim 18, wherein at least a portion of the flexibletubular sheath comprises a layer of a radiopaque material.
 58. Themedical device of claim 57, wherein the radiopaque material comprisesgold, platinum, tantalum, tungsten, iridium, rhodium, rhenium, or analloy of two or more radiopaque material.
 59. The medical device ofclaim 18, wherein a portion of the coil is covered with a radiopaquematerial.
 60. The medical device of claim 57, wherein the flexibletubular sheath is covered at its distal portion with a radiopaquematerial.
 61. The medical device of claim 18, wherein the coil portionof the guidewire fits into the flexible tubular sheath having an innerdiameter about 0.005 inches (0.127 mm) greater than the coil portion ofthe guidewire.